Non-union of FracturesNCT02177565
Autologous Stem Cell Therapy for Fracture Non-union Healing
A study testing carrier plus in vitro expanded autologous BMSCs in people with Non-union of Fractures, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Non-union of Fractures
- What is being tested?
- carrier plus in vitro expanded autologous BMSCs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2000to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An established non-union according to the US Food \& Drug Administration criteria14.
- Non-union following fracture of tibia or femur suitable for synthetic bone grafting.
Who cannot join
- Skeletal immaturity.
- Pregnant or breast-feeding.
- Non-union following pathological fractures.
- Positive to Hepatitis B, Hepatitis-C or HIV.
- Infection during BMSC culture.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Robert Jones & Agnes Hunt Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG
About this study
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.
Read the detailed description
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.
- Conditions
- Non-union of Fractures
- Being tested
- carrier plus in vitro expanded autologous BMSCs
- Keywords
- Non-union, fracture, bone marrow stem cells
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carrier plus in vitro expanded autologous BMSCsBiological
The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container
| Study group | Role | What they receive |
|---|---|---|
| carrier plus BMSCs | Experimental | carrier plus in vitro expanded autologous BMSCs Receives: Biological: carrier plus in vitro expanded autologous BMSCs |
| carrier alone (control). | Placebo comparator | Carrier alone Receives: Biological: carrier plus in vitro expanded autologous BMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological assessment of new callus and fracture bridging
The primary outcome measure was formation of new callus and cortical bridging, assessed from pre-operative and multiple post-operative radiographs and CT-scans up to 12 months. These images were divided into early (0-3 months) and late (9-12 months) groups. Non-unions were assessed from anonymized slides by four independent reviewers (two radiologists and two orthopedic surgeons) blinded to the side of cell insertion. Each slide had a pre-operative radiograph for comparison but no indication of time since surgery, and showed a medial/ lateral or an anterior/ posterior view depending on the surgical approach . At first, each reviewer indicated the side with largest callus and most cortical bridging pre-operatively. Then each reviewer examined subsequent radiographs to indicate the side with the largest increase in new callus and cortical bridging.
Measured: 12 months
Secondary outcomes (1)
EQ-5D
Change in EQ-5D index at 1 year was used as secondary outcome measures.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJan 2000
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-union of FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Collaborators
- Keele University
- Responsible party
- Sponsor
- Investigators
- James Richardson, FRCS MD, Principal investigator, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177565
- Sponsor's protocol ID
- RL1 254
- Other IDs
- Issuing Organisation
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Stem Cell Therapy for Fracture Non-union Healing
- ClinicalTrials.gov ID
- NCT02177565
- Acronym / sponsor ID
- RL1 254
- Conditions
- Non-union of Fractures
- Keywords
- Non-union, fracture, bone marrow stem cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Collaborators
- Keele University
- Study start
- Jan 2000
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.
Detailed description
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carrier plus BMSCs | Experimental | Biological: carrier plus in vitro expanded autologous BMSCscarrier plus in vitro expanded autologous BMSCs |
| carrier alone (control). | Placebo comparator | Biological: carrier plus in vitro expanded autologous BMSCsCarrier alone |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- An established non-union according to the US Food \& Drug Administration criteria14.
- Non-union following fracture of tibia or femur suitable for synthetic bone grafting.
Key exclusion criteria (5 listed)
- Skeletal immaturity.
- Pregnant or breast-feeding.
- Non-union following pathological fractures.
- Positive to Hepatitis B, Hepatitis-C or HIV.
- Infection during BMSC culture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carrier plus in vitro expanded autologous BMSCsThe non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container | Biological | carrier alone (control)., carrier plus BMSCs |
Primary outcome
Radiological assessment of new callus and fracture bridging
Time frame: 12 months
The primary outcome measure was formation of new callus and cortical bridging, assessed from pre-operative and multiple post-operative radiographs and CT-scans up to 12 months. These images were divided into early (0-3 months) and late (9-12 months) groups. Non-unions were assessed from anonymized slides by four independent reviewers (two radiologists and two orthopedic surgeons) blinded to the side of cell insertion. Each slide had a pre-operative radiograph for comparison but no indication of time since surgery, and showed a medial/ lateral or an anterior/ posterior view depending on the surgical approach . At first, each reviewer indicated the side with largest callus and most cortical bridging pre-operatively. Then each reviewer examined subsequent radiographs to indicate the side with the largest increase in new callus and cortical bridging.
1 secondary outcome
EQ-5D
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Richardson, FRCS MD principal investigator
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carrier plus in vitro expanded autologous BMSCs in people with Non-union of Fractures, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological assessment of new callus and fracture bridging (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.